ACTION:
Notice of application.
DATES:
Registered bulk manufacturer of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 6, 2020.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.33(a), this is notice that on August 6, 2019, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
Controlled substance | Drug code | Schedule |
---|---|---|
Marihuana | 7360 | I |
Tetrahydrocannabinols | 7370 | I |
Codeine-N-oxide | 9053 | I |
Dihydromorphine | 9145 | I |
Hydromorphinol | 9301 | I |
Morphine-N-oxide | 9307 | I |
Amphetamine | 1100 | II |
Methylphenidate | 1724 | II |
Nabilone | 7379 | II |
Phenylacetone | 8501 | II |
Codeine | 9050 | II |
Dihydrocodeine | 9120 | II |
Oxycodone | 9143 | II |
Hydromorphone | 9150 | II |
Hydrocodone | 9193 | II |
Morphine | 9300 | II |
Oripavine | 9330 | II |
Thebaine | 9333 | II |
Opium extracts | 9610 | II |
Opium fluid extract | 9620 | II |
Opium tincture | 9630 | II |
Opium, powdered | 9639 | II |
Opium, granulated | 9640 | II |
Oxymorphone | 9652 | II |
Noroxymorphone | 9668 | II |
Tapentadol | 9780 | II |
The company plans to manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.
Dated: October 22, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-24106 Filed 11-4-19; 8:45 am]
BILLING CODE 4410-09-P